Kornimate/medical-research-clean huggingface dataset:
effect of lactobacillus gasseri dsm 27123 on functional constipation in healthy women

Conditions: Functional Constipation

Summary: the primary objective is to determine the change in frequency of complete spontaneous bowel movements (csbms) after 4 weeks of oral supplementation with lactobacillus gasseri dsm 27123 in healthy adult women with functional constipation.

subjects to complete study diaries, number of sbm, csbm, form of faeces (according to the bristol stool form scale), pain during defecation (according to the visual analogue scale \[vas\] 0-100), time spent at each evacuation, episodes of faecal incontinence, number of ingested capsules of investigational product will be recorded daily by the subjects

Eligibility criteria:
inclusion criteria: the subjects have to meet all of the following criteria to be eligible to enter the study: 1. willing and able to provide informed consent 2. women aged 18-49 years at visit 1 3. bmi ≥18 and ≤29 at visit 1 4. suffering of functional constipation as defined by the rome iii criteria for functional constipation 5. comply with the requirement not to use any other probiotic products from visit 1 and throughout the study period 6. not pregnant or breastfeeding 7. using adequate contraceptive measures 8. ability to understand and comply with the requirements of the study, as judged by the investigator exclusion criteria: 1. hypersensitivity or allergy to the investigational product, to chemically related products or to comparator/placebo 2. well-known, organic cause of constipation 3. anorectal pathology 4. previous gastrointestinal surgery 5. any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the investigator 6. spinal anomalies and injuries 7. use of antibiotics within 4 weeks prior to visit 1 8. use of products containing probiotics more than once a week in the previous 3 weeks 9. mental or behavioural disorders as judged by the investigator 10. food allergy

Keywords: female constipation lactobacillus gasseri dsm 27123 probiotics
effect of genetic polymorphisms on the clinical response to sglt2 inhibitors in heart failure patients

Conditions: Genetic Polymorphisms; Heart Failure

Summary: sodium-glucose cotransporter 2 (sglt2) inhibitors have shown further reductions in heart failure hospitalization, cardiovascular events, and mortality, especially for heart failure patients. the sglt2 gene, also known as slc5a2 (solute carrier family 5 member 2), is located on chromosome 16 and is responsible for encoding sglt2. several slc5a2 mutations alter sglt2 expression, membrane location, or transporter function. several common genetic variations were found in the slc5a2 gene that may affect the response to treatment with sglt2 inhibitors.

sodium-glucose cotransporter-2 inhibitors (sglt-2i), which were first investigated and licensed for the treatment of diabetes, are now emerging as a promising class of drugs for the treatment of heart failure (hf), even in people without diabetes. significant reductions in worsening heart failure or cardiovascular death were shown under treatment with dapagliflozin and empagliflozin in the trials of patients with heart failure. several common genetic variations were found in the slc5a2 gene that may affect the response to treatment with sglt2 inhibitors. the most recent slc5a2 single nucleotide polymorphisms (snps) that reduce the risk of heart failure included two intronic slc5a2 snps, s9934336, and rs3116150, both associated with the expression levels of the transporter. this study aims to detect the association between slc5a2 single nucleotide polymorphisms and variability in response to sglt2 inhibitors as well as the association between cardiac biomarkers and non-coding rna in patients with heart failure.

Eligibility criteria:
inclusion criteria: * heart failure patients nyha class ii to iii. * heart failure patients with reduced left ventricular ejection fraction (lvef) \ 45% * patients who will be candidate for add-on treatment with sglt2. * patients who will be able to sign informed consent to participate in the study. exclusion criteria: * contraindications to sglt2. * significant coronary artery diseases (cad), coronary artery bypass grafting (cabg), percutaneous coronary intervention (pci), or valve surgery within 3 months. * pregnant or breastfeeding women. * patients with estimated glomerular filtration rates less than 30 ml/min/1.73 m2, as determined using the ckd-epi equation.
nutrition and movement to improve quality of life with knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: this project aims to evaluate the effects of an evidence-based training program in combination with an antiinflammatory dietetic intervention on quality of life for patients with knee osteoarthritis

osteoarthritis (oa) is the most prevalent arthritic disease worldwide characterized by pain, effusion and stiffness leading to functional decline and reduced quality of life (ql). it has been long considered as a degenerative disease of cartilage resulting from bodily wear and tear that affect the entire joint structure. however, there is accumulating evidence that inflammation plays a key role in the oa pathogenesis. triggered from tissue damage and by metabolic dysfunction, inflammatory processes within the joint may trigger the development of chronic low-grade inflammation. factors that contribute to chronic low-grade inflammation include a nutrient overload, a metabolic surplus, pro-inflammatory cytokines and adipokines. knee oa is the most common form of oa with prevalence rising with age peaked at around 50 years of age affecting more than 250 million people worldwide. exercise therapy (et) is an effective component of early treatment and is therefore recommended as a first line treatment. good life with osteoarthritis in denmark (gla:d®) represents an evidence-based treatment plan for knee oa and optimizes the implementation of et. however, et mainly addresses physical and functional deficits in patients with knee oa, but not the inflammatory processes. due to the association of chronic low-grad inflammation with dietary patterns, nutrition plays a significant role in inflammation-related diseases. a plant-based, anti-oxidative and anti-inflammatory therapeutic diet helps to improve symptoms leading to improved quality of life. when implementing a therapeutic diet, it should be attractive for patients and regional needs should be considered. this might increase adherence to therapeutic diet and will have an environmental impact - the new nordic diet (nnd) seems to fulfil these requirements. to our knowledge no study has examined the influence of nnd on symptoms and ql in oa. further, there is a lack of knowledge concerning the impact of exercise therapy and nutrition therapy on symptoms and ql in patients with knee oa. aims 1. to evaluate the effect of a nutrition therapy combined with exercise therapy on ql in patients knee oa 2. to investigate the impact of a nutrition therapy combined with exercise therapy on symptoms, nutrition and inflammation status and joint function in patients with knee oa

Eligibility criteria:
inclusion criteria: * mild to moderate knee osteoarthritis exclusion criteria: * musculosceletal disorders which obviates a participation in the training program * kognitive deficits * internal, neurological and mental diseases * drug and/or alcohol abuse

Keywords: knee osteoarthritis exercise therapy nutrition quality of life
clinical trial enzyme application targeting venous leg ulcers

Conditions: Venous Leg Ulcer; Leg Injuries and Disorders

Summary: this is an adaptive open-label, first-in-human (phase iia) study designed to assess the safety (and efficacy) of aurase wound gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (vlu)

the study has been designed as a dose escalation study, and will serially explore increasing concentrations of the aurase enzyme in a relevant patient population. five cohorts (of 10 patients each, except cohort 1 with 5 patients), will receive standard of care supplemented with increasing concentrations of aurase and will be assessed for clinical tolerability at the wound site, systemic safety and efficacy (extent of wound debridement) over a period of 4 weeks. patients will receive a total of 12 doses of aurase wound gel. at the end of the study, patients will revert to standard of care only.

Eligibility criteria:
inclusion criteria: * male or female patients aged 18 years and older at screening * patients with at least one defined venous leg ulcer (vlu) suitable for treatment that is no smaller than 2cm2 but no larger than 50cm2 * presence of devitalised tissue within the reference ulcer suitable for debridement therapy * confirmed, clinically diagnosed vlu (30 days or more) which has been present for less than 2 years * willing and able to attend and comply with study visits and study related activities exclusion criteria: * diabetic foot ulcer * a clinical history of a bleeding disorder including haemophilia, purpura, or thrombocytopenia * current or history of use of anti-thrombotic therapy less than 7 days prior to screening. * stage 4 or 5 chronic kidney disease, defined as estimated glomerular filtration rate (egfr) less than or equal to 30 ml/min * reference ulcer has active infection or florid oedema at screening * oral or intravenous antibiotics for any indication within 72 hours of screening * reference ulcer has exposed tendons, ligaments, muscle, or bone * active osteomyelitis, cellulitis or gangrene in either leg * patients with amputation above a trans metatarsal amputation (tma) in the target leg * planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 4 weeks before screening

Keywords: wounds chronic leg ulcer leg ulcer venous leg ulcer
multiple sclerosis and pilates

Conditions: Multiple Sclerosis

Summary: pilates is becoming popular among the multiple sclerosis (ms) community as an alternative to the more traditional exercise programs. although somewhat limited, previous research has suggested pilates may have some beneficial effects in ms. this 12-week, single-blinded, randomized controlled study has one intervention group (pilates and massage therapy) and one control group (massage therapy only). the primary outcome of interest is the change in walking ability between groups. secondary outcomes include other measures of physical performance and quality of life.

in the recent 2015 ms society of canada ms wellness survey almost 25% of people indicated that they think physical activity is the most important area of wellness, yet physical inactivity is still common in individuals with multiple sclerosis (ms). while some of this may be due to factors related to ms such as fatigue, pain, and physical restrictions, research has shown that exercise has beneficial effects on mobility, strength, balance, and overall quality of life. however, because the symptoms of ms vary, there is not one optimal exercise program that exists. pilates may be a good exercise option for ms. pilates focuses on body positions and movement, with specific attention on the core (stomach or trunk) muscles. very few researchers have studied pilates in ms, but those that have, noticed some improvements in walking, balance, and strength. there were no negative effects reported from the pilates exercises, and the exercises can be adapted for all levels of ability in ms. we are interested in studying the effect of pilates in ms. to do this, we will recruit 30 people with ms to participate in this study. participants will be randomly put into either the pilates group or the control group. those individuals in the pilates group will attend two 50-minute pilates classes twice weekly, plus receive a weekly 1-hour massage therapy session. individuals in the control group will only receive the weekly massage therapy session. at the end of the study (12 weeks), we will look to see if there are any differences between the two groups in walking ability. we will also compare other important outcomes such as muscle strength, balance, and quality of life between the two groups. results from this study may provide individuals with another exercise option to help manage their ms and improve their wellness. results will also be useful for organizations such as the ms society to help make decisions about which programs and services to offer to individuals with ms.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis exclusion criteria: * expanded disability status scale of 8 or higher
effect of gastric lavage in preventing feeding problems in babies born with meconium stained amniotic fluid

Conditions: Gastritis of Newborn; Other Vomiting of Newborn; Meconium in Amniotic Fluid

Summary: the purpose of the study is to evaluate the role of gastric lavage in preventing feeding problems in babies born through meconium stained amniotic fluid. it is a routine practice in many hospitals to perform gastric lavage in all babies born with meconium stained amniotic fluid after stabilisation without any supporting evidence. it is believed that meconium is an irritant and its presence in stomach causes gastritis and vomiting and hence the basis for this practice. orogastric tube insertion and subsequent gastric lavage is not without complications. potential complications will be prevented and health resources will be saved if this procedure is not proven to be beneficial. therefore the investigators decided to study if gastric lavage reduces incidence of vomiting and other feeding difficulties as well as incidence of respiratory difficulties in babies born with msaf.

meconium passage in newborn infants is a developmentally programmed event normally occurring within first 24-48 hours of birth. the meconium staining of amniotic fluid occurs in 12% of all live births per annuum. the routine use of gastric lavage in msaf babies has been advocated for a long time as a part of the conventional treatment. meconium in stomach is hypothesized to act as an irritant and cause vomiting and retching. surprisingly this recommendation is also made in some textbooks without supporting evidence. orogastric tube insertion and subsequent gastric lavage can cause complications like bradycardia, apnea, vomiting, trauma, aspiration and esophageal or gastric perforations. some researchers have found that gastric suction done at birth is associated with long term risk for functional intestinal disorder. the sequence of prefeeding behaviour is disrupted in children who undergo gastric suction and it can delay initiation of breast feeding. small elevation in mean arterial blood pressure, increased retching have also been reported the role of gastric lavage in preventing feeding problems and secondary meconium aspiration syndrome has not been systematically evaluated. if this procedure is not proven to be beneficial it will prevent potential complications which may arise due to it in a significant number of babies. also in a resource limited country the cost of materials required and time of medical personnel will be saved. hence the purpose of this prospective randomized controlled trial is to compare the incidence of feeding problems and secondary meconium aspiration syndrome, in gastric lavage group vs no lavage group.

Eligibility criteria:
inclusion criteria: * gestation \> 34 weeks * meconium staining of amniotic fluid * vigorous babies exclusion criteria: * major congenital malformation * non vigorous babies * refusal of consent

Keywords: gastric lavage neonate meconium stained amniotic fluid feeding problems
parent and infant inter(x)action intervention (pixi)

Conditions: Fragile X Syndrome; Angelman Syndrome; Prader-Willi Syndrome; Dup15Q Syndrome; Duchenne Muscular Dystrophy; Phelan-McDermid Syndrome; Rett Syndrome; Smith Magenis Syndrome; Williams Syndrome; Turner Syndrome; Klinefelter Syndrome; Chromosome 22q11.2 Deletion Syndrome; Tuberous Sclerosis; Down Syndrome

Summary: the objective is to develop and test, through an iterative process, an intervention to address and support the development of infants with a confirmed diagnosis of a neurogenetic disorder with associated developmental delays or intellectual and developmental disabilities. the proposed project will capitalize and expand upon existing empirically based interventions designed to improve outcomes for infants with suspected developmental delays. participants will be infants with a confirmed diagnosis of a neurogenetic disorder (e.g., fragile x, angelman, prader-willi, dup15q, phelan-mcdermid, rhett, smith magenis, williams, turner, kleinfelter, down syndromes, duchenne muscular dystrophy) within the first year of life and their parents/caregivers. the intervention, called the parent and infant inter(x)action intervention (pixi) is a comprehensive program inclusive of parent education about early infant development and the neurogenetic disorder for which they were diagnosed, direct parent coaching around parent-child interaction, and family/parent well-being support. the protocol includes repeated comprehensive assessments of family and child functioning, along with an examination of feasibility and acceptability of the program.

the primary goal of the proposed project is to develop and test, through an iterative process, an intervention to address and support the development of infants with a rare neurogenetic condition (e.g., fragile x, angelman, prader-willi, dup15q, phelan-mcdermid, rhett, smith magenis, williams, turner, kleinfelter, down syndromes, duchenne muscular dystrophy) identified prior to emergence of symptoms. pixi aims to utilize the foundational knowledge available around the development of and early intervention for at-risk infants to both understand the needs of and provide intervention services for families of infants diagnosed pre-symptomatically with rare neurogenetic disorders. the investigators aim to 1) develop pixi with a pilot sample of families, 2) test the preliminary effects of pixi on infant and parent outcomes

Eligibility criteria:
inclusion criteria: * infants 15 months of age or younger who have received a diagnosis which was not sought solely due to parental concerns about the infant (e.g. diagnosis due to prenatal or newborn screening, cascade testing following diagnosis of a family member). * english must be the primary language spoken in the home because all assessment measures and intervention protocol are in english. exclusion criteria: - infants may not be blind or have a severe hearing impairment as the intervention and assessments are not appropriate for these children.

Keywords: early intervention parent-child interaction rare neurogenetic conditions intellectual and developmental disabilities
assessment of eyeart performance with retinal cameras

Conditions: Diabetic Retinopathy

Summary: the study evaluates the performance of the eyeart system for detecting diabetic retinopathy from images captured using retinal cameras and operators.


Eligibility criteria:
inclusion criteria: * a diagnosis of diabetes mellitus; * understanding of study and provision of written informed consent; and * 22 years of age or older. exclusion criteria: * persistent visual impairment in one or both eyes; * history of retinal vascular (vein or artery) occlusion; * history of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications; * subject is contraindicated for fundus photography (for example, has light sensitivity); * subject has contraindications for mydriatic medications or is unwilling or unable to dilate; * subject is currently enrolled in an interventional study of an investigational device or drug; or * subject has a condition or is in a situation which in the opinion of the investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable dilated fundus photographs.
creation of an image database for the development of a computer aided diagnostic (cad) system in patients with prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is currently detected by ultrasound-guided biopsy. computer-aided diagnostic (cad) systems based on multiparametric mri are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. we hypothesize that combining mri and ultrasound imaging can improve the detection of cancerous tumors. as a first step in this direction, we need to create a database with mr images, 3d ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. this is the purpose of the present study. in a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new cad system, and we will assess the performance of the new cad. we expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.


Eligibility criteria:
inclusion criteria: * patient referred for radical prostatectomy * patient with multiparametric prostate mri (3t) performed in our institution (edouard herriot hospital) in the year preceding the surgery * informed consent signed * patient affiliated to the french health insurance system exclusion criteria: * history of prostatic surgery or radiation therapy (prostatic or pelvic) * history of hormone therapy for prostate cancer * previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound * patient on protection of the court, under supervision or under trusteeship * inability to express a consent

Keywords: prostate cancer computer-aided diagnosis